With less than a year until the new Machinery Regulation 2023/1230 supersedes the Machinery Directive 2026/42/EC, and no transition period, machine builders must get ready.
One-off and series machines all have to be CE marked to the new Machinery Regulation (MR) if they will be sold in the EU on or after 20th January 2027.
While the new MR is very similar to the old Machinery Directive (MD), there are important differences. Some relate to additional essential health and safety requirements, such as those for cybersecurity and artificial intelligence, but others are administrative and entail revisions to paperwork.
For a start, the technical documentation (previously referred to as the technical file) must contain more detail, and the EU Declaration of Conformity (previously the EC Declaration of Conformity) has to be updated in several ways.
Depending on the machine, even if it has been designed in accordance with the MD harmonised standards, all or part of it might need a fresh risk assessment against the EHSRs in the new MR. The results of the risk assessment could potentially require changes to the machine, including to the control system and software. A particular challenge here is that the European Commission has not yet published the harmonised standards for the MR!
One of the benefits of the new MR is that it no longer stipulates that a printed copy of the user instructions be supplied with every machine, as digital versions are now permitted. Although this could save money for machine builders, customers can request, free of charge, a printed copy of the instructions when placing an order.
Another way the MR differs from the MD is that it includes clauses about economic operators. In fact, these are essentially the same as in EU regulation 2019/1020 on market surveillance and compliance, which has been in force for around five years. By now, most machine builders exporting to the EU will have mandated an EU Authorised Representative (EU AR) to act as an economic operator; any that are yet to do so should make this a priority. Without an economic operator named on the paperwork, a machine could be held at the border.
20th January 2027 is less than a year away, and lead times for complex machinery can be considerable. Even if machine builders only need to update their paperwork, it will take time to study the new Machinery Regulation and ascertain what actions to take.
Hold Tech Files Ltd is established in the Republic of Ireland and can act as an EU AR. Furthermore, its consultants can provide advice to help machine builders prepare for the new Machinery Regulation.
For more information, contact Hold Tech Files Ltd. www.holdtechfiles.eu
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